Free Biopharma Daily Stock Updates - 09/13/21

$XBI $131.08 -0.50%

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Covid Updates

$TNXP -0.80% Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA for TNX-1800 as a Potential Vaccine to Prevent COVID-19. source

$DVAX -16.0% Dynavax Provides Update on its COVID-19 Collaboration with Valneva. source

$VALN -40.0% Valneva Receives Notice of Termination of COVID-19 Vaccine Supply Agreement by UK Government. source

Pipeline Updates

$INCY +1.9% Incyte Announces Ruxolitinib Cream Data Accepted for Presentation at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress source

$JAZZ +0.2% Jazz Pharmaceuticals Announces Xywav® (calcium, magnesium, potassium, and sodium oxybates) Investor Webcast on October 13, 2021 source

$CLDX -0.80% Celldex Announces Initiation of CDX-0159 Subcutaneous Formulation Study. source

$YMAB +1.1% Y-mAbs Announces Priority Review of BLA for DANYELZA® (naxitamab-gqgk) in China. source

$DMAC +3.7% DiaMedica Therapeutics Initiates Pivotal Trial of DM199 for the Treatment of Acute Ischemic Stroke. source

$IBRX -1.2% ImmunityBio Announces Positive Durable Responses in BCG Unresponsive Bladder Cancer Patients with a Complete Response Rate of 72%, Median Duration of Complete Response of 19.9 Months, and 85% Remaining Cystectomy-free in Phase 2/3 Trial. source

$LEGN -1.6% Legend Biotech Begins Phase 1 Clinical Trial in the US to Evaluate Investigational Anti-CD4 CAR-T Therapy for Relapsed or Refractory T-Cell Lymphoma. source

$OTLK +1.2% Outlook Therapeutics Presents Positive NORSE THREE Safety Data for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) at EURETINA Virtual 2021 Medical Conference. source

$GLTO -2.3% Galecto Announces First Patient Treated in Phase 2 Trial of Oral Galectin-3 Inhibitor GB1211 in Liver Cirrhosis. source

$BLU +22.0% BELLUS Health Announces Positive Interim Analysis from the Phase 2b SOOTHE Trial of BLU-5937 in Refractory Chronic Cough. source

$PRVB +4.0% Provention Bio Provides Update on the Potential Timing of Teplizumab At-Risk Type 1 Diabetes (T1D) Biologics License Application (BLA) Resubmission. source

$ADCT +1.0% ADC Therapeutics Receives Orphan Drug Designation in Europe for ZYNLONTA®. source

$TARA -1.0% Protara Therapeutics Announces Results from a Retrospective Study Evaluating the Prevalence of Cholestasis in Patients Dependent on Parenteral Nutrition. source

$RDHL -8.7% RedHill Biopharma Accelerates Ongoing U.S. Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients with South African Approval. source

$ADAP -6.4% Adaptimmune Announces Clinical Responses across Five Solid Tumor Indications with an Overall Response Rate of 36% and Promising Early Durability from its Next-Generation SURPASS Trial. source

$AMRN -0.6% Amarin Announces First European Launch of VAZKEPA (icosapent ethyl) in Germany. source

$ZYNE -0.5% Zynerba Pharmaceuticals Initiates RECONNECT, a Pivotal Phase 3 Trial of Zygel™ in Fragile X Syndrome. source

$ZNTL +3.1% Zentalis Pharmaceuticals Announces First Patient Dosed in the Phase 1/2 Study of ZN-c3 in Combination with Gemcitabine in Patients with Osteosarcoma . source

$TIL +3.3% Instil Bio Receives IND Clearance to Initiate a Phase 2 Clinical Trial for Patients with Advanced Melanoma. source

$TCRR +1.4% TCR2 Therapeutics to Announce Extended Results from Ongoing Phase 1/2 Trial of Gavo-cel in Mesothelin-Expressing Solid Tumors. source

$MIRM -1.2% Mirum Pharmaceuticals Submits European Marketing Authorization Application for Maralixibat in Alagille Syndrome Supported by New Positive Results from Natural History Study Comparison. source

$SQZ +1.7% SQZ Biotechnologies Announces First Autoimmune Disease Indication for Tolerizing Antigen Carrier (TAC) Platform. source

$VTGN +-0.0% VistaGen Therapeutics Further Advances PALISADE Phase 3 Program for PH94B in Social Anxiety Disorder with Initiation of PALISADE-2. source

$MTNB +27.1% Matinas BioPharma Announces Positive Data in the Ongoing EnACT Trial of MAT2203 (Oral Amphotericin B) for the Treatment of Cryptococcal Meningitis, Exceeding the Prespecified Primary Endpoint Threshold. source

$HCM +3.0% HUTCHMED Receives Breakthrough Therapy Designation in China for Amdizalisib (HMPL-689) for Treatment of Relapsed or Refractory Follicular Lymphoma. source

$CYTK +6.6% Cytokinetics Announces Results From REDWOOD-HCM and GALACTIC-HF Presented in Late Breaking Clinical Trial Session at the HFSA Annual Scientific Meeting. source

Finance & Business Updates

$ABCL -6.6% AbCellera Acquires TetraGenetics, Enhancing Capabilities to Generate Antibodies Against High-Value Targets. source

$ACET -1.6% & $TWST -4.5% Adicet Bio Collaborates with Twist Bioscience to Accelerate Discovery of Gamma Delta T Cell Cancer Therapeutics. source

$SIGA -0.6% SIGA Announces BARDA Exercise of Procurement Option Valued at $112.5 Million for Oral TPOXX®. source

$LNTH -3.4% Lantheus and RefleXion Announce Development and Commercialization Collaboration with the Potential to Improve Future Prostate Cancer Treatment. source

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Posted by FS/JM